1. Technical Field
The present disclosure relates to the field of medical fluid transfer devices, and more particularly, to methods and apparatus for safely transferring bodily fluids to a receptacle.
2. Description of the Related Art
In the medical field, specimens of blood or other bodily fluids are commonly obtained from a subject using a syringe and hypodermic needle or a hypodermic needle connected to a fluid collection system. Health care workers who handle fluid samples and collection apparatus are routinely exposed to dangers from inadvertent contact with contaminated needles or exposure to contaminated bodily fluids. Rigorous safety precautions must be exercised to prevent exposure to fluid samples or contaminated needles.
It is often desirable to transfer blood or other bodily fluids collected from a patient to one or more receptacles, for example, to be stored or taken to a lab for testing. Various sized receptacles such as specimen culture bottles and vials are commonly used to receive bodily fluid specimens. It is well known to cover the entry portion of a receptacle with a pierceable rubber septum which seals the entry portion and to facilitate fluid transfer to and from the receptacle. The septum is pierced by the needle or cannula of a fluid transfer device such as a medical syringe containing the fluid to be transferred. Fluid can then be safely transferred from the fluid transfer device to the receptacle. When the needle or cannula is withdrawn from the pierceable septum, the septum substantially reseals itself thereby preventing fluid from escaping the receptacle and preventing contaminants from entering the receptacle.
Fluid transfer devices such as blood collection devices are commonly adapted for transferring samples to more than one receptacle. At least one type of multiple sample adapter for a fluid transfer device provides a needle covered by a pierceable rubber sheath. Like the pierceable septum, the pierceable sheath is capable of resealing itself after a needle is withdrawn. Upon use, the needle of a multiple sample adapter pierces the rubber sheath and the septum of a receptacle. The septum allows the needle to pass into a receptacle but blocks entry of the sheath. The sheath is thus compacted along the needle shaft as the needle advances further through the sheath and the septum. As the needle is withdrawn from the receptacle, the sheath resiliently springs back along the needle shaft. When the needle tip clears the septum, the sheath takes its original shape thereby covering and sealing the needle.
A serious risk is encountered by health care workers when a needle is uncovered. The rubber sheath of a multiple collection device does not protect health care workers from accidental needle stick injuries. An accidental needle stick can be caused, for example, by slipping or improperly aiming a needle while attempting to puncture the septum of a receptacle.
Various methods and apparatus are known for reducing the risk of inadvertent contact with contaminated needles while transferring blood to a receptacle. U.S. Pat. No. 5,360,423 to McCormick (hereinafter “McCormick '423) describes a safety system for transfer and collection of body fluids. McCormick '423 describes a cup shaped guide port adaptable over a fluid transfer needle wherein the needle is recessed rearward from an open end of the guide port. An open end of the cup shaped guide port guides a fluid receiver into contact with the needle to reduce the likelihood of a needle-stick injury to a health care worker. A plurality of sized guide ports are described to guide a transfer needle into contact with a variety of fluid receivers.
McCormick '423 also describes a cap adaptable to the open end of the guide port. The cap substantially covers the open end of the guide port to reduce exposure risk to health care workers. The cap also includes a centered aperture for guiding a smaller receptacle such as a vial into contact with the needle.
Guide ports and other heretofore known safety apparatus for fluid transfer needles suffer from various drawbacks. For example, the cap described in McCormick '423 must be manually aligned and pushed onto the open end of the guide port. The finger of a health care can accidentally slip inside the guide as the health care worker attempts to install the cap onto the guide. Therefore, although the guide cap of McCormick '423 is intended to protect the health care worker, it requires an installation step that can endanger the health care worker.
The guide port described in McCormick '423 also does not provide a lead-in structure to guide a vial through the opening in the cap and into the guide port. Rather, the cap described in McCormick '423 includes a flange or outwardly directed edge around the smaller opening. The flange or outwardly directed edge can impede the installation of a vial through the opening.
The cap described in McCormick '423 contacts a vial only around a narrow circumference at a proximal position on the vial. Therefore, the center axis of the vial is not robustly aligned and located relative to the center axis of a needle. The vial's freedom of movement can allow lateral movement of the vial's septum relative to the needle tip. Lateral movement of the septum relative to the needle can tear the septum which can prevent the septum from resealing properly after use. Such tears can allow dangerous fluids to escape from the receptacle or allow contamination into a receptacle. Lateral movement of a vial or receptacle relative to the needle can similarly tear a needle sheath and allow dangerous fluid to escape from a fluid transfer device.
Various guide ports heretofore known must be provided in a plurality of sizes to accommodate a variety of receptacle sizes. Heretofore known guide ports are also typically designed for use with a single fluid transfer device. The single fluid transfer device typically includes a needle permanently mounted inside of the guide port and permanently attached to tubing or a syringe mounted outside of the guide port. The needle is connected to the tubing or syringe via at a neck portion of the guide port.
Therefore, it would be desirable to overcome the disadvantages and drawbacks of the prior art with a guide port including a sleeve that substantially fills the cavity inside the guide port preventing a user who is holding the sleeve on the outside rim from having his finger slip between the sleeve and the needle. It would be desirable if such a guide included a sleeve having a robust external lead-in structure for aligning/assembling and centering the sleeve in the guide and a robust internal lead-in structure for aligning and centering a vial onto a needle. It would be desirable to provide a guide that engages long section of the outer surface of a vial thereby preventing rocking of a receptacle or lateral motion of the septum relative to the needle tip. It would also be desirable to provide a guide adapted to fit a variety of sized receptacles. It would also be desirable to guide port adapted for use with multiple fluid transfer devices.